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Trial record 9 of 53 for:    "Central serous chorioretinopathy"

Eplerenone for the Treatment of Central Serous Chorioretinopathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01990677
First Posted: November 21, 2013
Last Update Posted: June 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Mid Atlantic Retina
Information provided by (Responsible Party):
MidAtlantic Retina, Wills Eye
  Purpose
To test the effect oral eplerenone versus placebo in patients with central serious chorioretinopathy .

Condition Intervention
Central Serous Chorioretinopathy Drug: 25mg Eplerenone Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Eplerenone for the Treatment of Central Serous Chorioretinopathy

Resource links provided by NLM:


Further study details as provided by MidAtlantic Retina, Wills Eye:

Primary Outcome Measures:
  • Maximal Subretinal Fluid Height Based on Spectral Domain Optical Coherence Tomography (OCT) Measurement. [ Time Frame: At 1 month in acute CSCR and 2 months in chronic CSR patients ]
    Placebo versus eplerenone acute CSCR patients will have sub-foveal fluid measured at month 1, and placebo versus eplerenone chronic cscr patients will be have sub-foveal fluid measured at month 2.


Secondary Outcome Measures:
  • Mean Change in Subfoveal Fluid Height Based on OCT Measurement [ Time Frame: Month 1 for acute CSCR patients, Month 2 in chronic CSCR patients ]
    Placebo versus eplerenone acute CSCR patients will be measured at month 1 and placebo versus eplerenone chronic CSCR patients will be measured at month 2.


Other Outcome Measures:
  • Proportion of Patients Having a Reduction in Subfoveal Fluid on OCT Measurement [ Time Frame: Month 1 for acute CSCR patients and Month 2 for chronic CSCR patients. ]
    Placebo versus eplerenone acute CSCR patients will be measured at month 1 and placebo versus eplerenone chronic cscr patients will be measured at month 2.


Enrollment: 108
Study Start Date: October 2013
Study Completion Date: May 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 25mg Eplerenone- Chronic CSCR Diagnosis
Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 58 days. Throughout the 58 day treatment period dosage will be adjusted. The adjustment will be based on serum potassium and creatine levels from blood draws done at Day 12 and Day 33. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day.
Drug: 25mg Eplerenone
Patients will be given 25mg Eplerenone (or 50mg Eplerenone) or placebo throughout the study and the dosage will be based on the serum potassium/creatine levels. Patients will be randomized 2:1 such that 36 patients in each group will receive eplerenone and 16 patients in each group will receive placebo
Other Names:
  • Eplerenone
  • Inspra
Drug: Placebo
Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo.
Other Name: Sugar pill
Placebo Comparator: Placebo- Chronic CSCR Diagnosis
Dosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 58 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient.
Drug: Placebo
Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo.
Other Name: Sugar pill
Active Comparator: 25mg Eplerenone- Acute CSCR Diagnosis
Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 28 days. Throughout the 28 day treatment period, dosage will be adjusted based on serum potassium and creatine levels from blood draws done on Day 12. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day.
Drug: 25mg Eplerenone
Patients will be given 25mg Eplerenone (or 50mg Eplerenone) or placebo throughout the study and the dosage will be based on the serum potassium/creatine levels. Patients will be randomized 2:1 such that 36 patients in each group will receive eplerenone and 16 patients in each group will receive placebo
Other Names:
  • Eplerenone
  • Inspra
Drug: Placebo
Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo.
Other Name: Sugar pill
Active Comparator: Placebo- Acute CSCR Diagnosis.
Dosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 28 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient.
Drug: Placebo
Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo.
Other Name: Sugar pill

Detailed Description:
To evaluate the effect of oral eplerenone compared to placebo in patients with central serous chorioretinopathy (CSCR) on sub-foveal (small part of retina) fluid using optical coherence tomography (OCT).
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 and over
  • Ability to give written informed consent
  • Sub-retinal fluid under fovea seen on OCT
  • Diagnosis of CSCR: classification is at the discretion of the investigator, but general guidelines are

    1. Acute- first episode or symptoms less than one month prior to presentation
    2. Chronic- previously documented sub-foveal fluid, any prior treatment, symptoms for over 3 months, or <50% reduction in fluid thickness on OCT after 3 months.

Exclusion Criteria:

  • Age under 18
  • Impaired decision-making ability
  • At initial laboratory screening serum potassium >5.5 mEq/L (milliequivalent)
  • At initial laboratory screening serum creatinine >2 mg/dL in men and >1.8 mg/dL in women or decreased renal function by creatinine clearance less than 50 mL/min
  • Absence of sub-foveal fluid
  • Any patient with prior treatment for CSCR within 3 months of enrollment
  • Patients taking potassium supplements or potassium-sparing diuretics spironolactone, amiloride, and triamterene and/or potent CYP3A4 (cytochrome) inhibitors (amifostine, cyclosporine, fluconazole, itraconazole, ketoconazole, mifepristone, posaconazole, potassium salts, rituximab, tacrolimus, voriconazole nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir)
  • Women who are pregnant or are actively trying to conceive
  • Patients with type 1 or type 2 diabetes
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01990677


Locations
United States, New Jersey
Mid Atlantic Retina
Cherry Hill, New Jersey, United States, 08002
Mid Atlantic Retina
Marlton, New Jersey, United States, 08053
Mid Atlantic Retina
Mays Landing, New Jersey, United States, 08330
United States, Pennsylvania
Mid Atlantic Retina
Bala-Cynwyd, Pennsylvania, United States, 19004
Mid Atlantic Retina
Bethlehem, Pennsylvania, United States, 18020
Mid Atlantic Retina
Huntingdon Valley, Pennsylvania, United States, 19006
Mid Atlantic Retina
Lansdale, Pennsylvania, United States, 19446
Mid Atlantic Retina
New Wilmington, Pennsylvania, United States, 19803
Mid Atlantic Retina
Newtown Square, Pennsylvania, United States, 19073
Mid Atlantic Retina
Plymouth Meeting, Pennsylvania, United States, 19462
Sponsors and Collaborators
Wills Eye
Mid Atlantic Retina
Investigators
Principal Investigator: Mitchell Fineman, MD Mid Atlantic Retina
  More Information

Responsible Party: MidAtlantic Retina, Dr. Mitchell Fineman, Wills Eye
ClinicalTrials.gov Identifier: NCT01990677     History of Changes
Other Study ID Numbers: ECSelsior
ESCelsior2013 ( Other Identifier: Mid Atlantic Retina )
First Submitted: November 15, 2013
First Posted: November 21, 2013
Results First Submitted: April 12, 2017
Results First Posted: June 29, 2017
Last Update Posted: June 29, 2017
Last Verified: May 2017

Keywords provided by MidAtlantic Retina, Wills Eye:
Central Serous Chorioretinopathy
csr
cscr
eplerenone
vision
choroid
retina
acute
chronic

Additional relevant MeSH terms:
Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases
Eplerenone
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents